DRKS00027485Active, not recruitingPhase 1
Pharmacokinetics of mistletoe lectin in healthy volunteers after intravenous infusion of Helixor® P - HePPI-730-169-2021
Conditions
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Sponsor
- Helixor Heilmittel GmbH
- Enrollment
- 8
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
- Allocation
- N/a: Single Arm Study
- Masking
- Open (masking not used)
Eligibility Criteria
- Ages
- 18 Years to 45 Years (—)
- Sex
- Male
Inclusion Criteria
- •Legal capacity
- •Ability to understand the nature, scope and importance of the clinical trial and to follow the instructions of the investigator
- •Gender: male
- •Age = 18 years and = 45 years
- •non-smokers
- •Body mass index 18.5 - 28 kg / m2
- •Standard values for blood pressure, pulse, body temperature
- •Standard values for haematological, biochemical and coagulation parameters
- •Standard-compliant EKG
- •Existence of a personally signed and dated declaration of consent after verbal and written information about the benefits and risks of the clinical trial
Exclusion Criteria
- •Signs of clinically significant disease
- •Regular use of medication
- •Positive urine screening for drugs
- •A positive blood test for alcohol
- •Known drug allergy
- •Any allergic disease other than the investigator considers irrelevant for the purposes of this study
- •Positive HIV, hepatitis B or C serology
- •Medication or drug abuse or risky alcohol consumption (see chapter 6.1.1 for definition)
- •Donating blood within the last 3 months before starting the study
- •Difficult peripheral vein access
- •Mistletoe pretreatment in any form, including oral intake of food supplements containing mistletoe, phytopharmaceuticals or teas
- •Participation in another clinical trial
- •Subjects who are dependent on or employed by the sponsor or trial center
Investigators
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